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Mifepristone Versus Laminaria Insertion for Cervical Preparation Prior to Surgical Abortion at 14-16 Weeks (SAMi)

This study has been completed.
Sponsor:
Collaborator:
Society of Family Planning
Information provided by:
Boston University
ClinicalTrials.gov Identifier:
NCT00986921
First received: September 23, 2009
Last updated: April 4, 2011
Last verified: April 2011
History of Changes
  Purpose

Women who are requesting pregnancy termination at 14-16 weeks, who would normally have osmotic dilator insertion the day before their procedure, would be asked if they wanted to participate. Participants would be randomized to two groups: first, dilator insertion as usual, or second, mifepristone taken the day before the procedure.


Condition Intervention
Abortion
 Drug: mifepristone 200 mg
Device: osmotic dilator insertion

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Mifepristone vs. Laminaria Insertion for Cervical Preparation Prior to Surgical Abortion at 14-16 Weeks

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Boston University:

Primary Outcome Measures:
  • Time for completion of procedure [ Time Frame: Performance and completion of the abortion procedure takes 10-20 minutes. The length of the procedure is measured. The procedure occurs approximately 24 hours after enrollment. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Acceptability to subjects and staff [ Time Frame: This acceptability questionnaire takes about 5 minutes to administer. It is administered shortly after the primary outcome, which is one day after enrollment. The study is complete at that point. ] [ Designated as safety issue: No ]

Enrollment: 50
Study Start Date: October 2009
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: mifepristone
women in the mifepristone are would take mifepristone 200 mg the day before their procedure, and not have dilators inserted
 Drug: mifepristone 200 mg
mifepristone would be given the day before the procedure
Active Comparator: Standard osmotic dilators
Women assigned to this arm would have the standard procedure, which is insertion of osmotic dilators the day before the procedure
 Device: osmotic dilator insertion
osmotic dilators (3-6) would be inserted as usual the day before the procedure

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • women aged 18-45 having pregnancy termination at 14-16 weeks

Exclusion Criteria:

  • multiple gestation, pre-existing infection, contraindication to osmotic dilators, unable to obtain proper consent
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00986921

Locations
United States, Massachusetts
Boston Medical Center
Boston, Massachusetts, United States, 02118
Sponsors and Collaborators
Boston University
Society of Family Planning
Investigators
Principal Investigator: L B, MD, MPH Boston University
  More Information

No publications provided by Boston University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: confidential, MD, Boston University
ClinicalTrials.gov Identifier: NCT00986921     History of Changes
Other Study ID Numbers: SAMi
Study First Received: September 23, 2009
Last Updated: April 4, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Boston University:
Length of time for procedure to be completed
Need for additional dilation
Subject satisfaction with procedure

Additional relevant MeSH terms:
Mifepristone
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
 Contraceptives, Postcoital, Synthetic
Contraceptives, Postcoital
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Luteolytic Agents
Menstruation-Inducing Agents
Abortifacient Agents, Steroidal
Abortifacient Agents

ClinicalTrials.gov processed this record on May 19, 2013